Cellectar Biosciences Reports Third Quarter 2026 Financial Results and Provides Corporate Updates

(NASDAQ:CLRB) Cellectar Biosciences, Inc. announced its financial results for the quarter ended September 30, 2026, and provided a comprehensive corporate update. James Caruso, president and chief executive officer, stated the company remains focused on advancing iopofosine I 131 for potential registration and commercialization in Waldenström macroglobulinemia (WM). New sub-analysis efficacy data from the Phase 2b CLOVER-WaM trial were presented at the International Workshop for Waldenström Macroglobulinemia (IWWM), showing an overall response rate (ORR) of 87.5%, a major response rate (MRR) of 79.2%, a median duration of response (DoR) of 16.0 months, treatment free survival (TFS) of 19.1 months, and a clinical benefit rate (CBR) of 100% in patients treated immediately after BTKi therapy. Less than 10% of patients experienced treatment emergent adverse events (TEAE), with cytopenias being the only Grade 3 or higher TEAE. The company plans to present three posters at the American Society of Hematology Annual Meeting and Exposition (ASH 2026), including updated 12-month follow-up data and a new analysis showing longer duration of response in patients treated after only two prior lines of therapy. Preparations for the Phase 3 confirmatory trial of iopofosine I 131 in WM are advanced, with initial clinical trial sites activated; the trial will randomize 100 WM patients per arm and evaluate progression-free survival as the primary endpoint. The first patient is expected to be dosed in Q1 2027, and a New Drug Application (NDA) submission to the FDA is planned for the first half of 2027 seeking accelerated approval. The Phase 1b dosimetry trial of iopofosine I 131 in all WM treatment lines has been initiated, with data expected from 20-30 newly diagnosed and relapsed WM patients. A case study was reported of a 53-year-old patient with high-grade, double-hit diffuse large B-cell lymphoma (DLBCL) achieving a complete response lasting more than eight years after iopofosine I 131 treatment. The CLR 121125 (CLR 125) iodine-125 program for solid tumors continues enrolling in a Phase 1b trial for refractory triple-negative breast cancer (TNBC), with initial dosimetry and safety data expected in Q4 2026. The company hosted a webinar on its Phospholipid Drug Conjugate (PDC) platform, highlighting its potential for combining with various therapeutic molecules. As of September 30, 2026, cash and cash equivalents were $24,582,115, up from $13,196,033 at December 31, 2025, reflecting net proceeds of approximately $31.7 million from a May 2026 offering. The company believes this cash is adequate to fund operations into Q2 2027. Research and development expenses for Q3 2026 were $5,435,796, compared to $2,523,305 in Q3 2025, primarily due to the Phase 3 trial initiation and increased activity in the CLR 125 trial. General and administrative expenses for Q3 2026 were $2,668,219, up from $2,327,391 in Q3 2025, mainly due to higher professional fees and personnel costs. Net loss attributable to common stockholders for Q3 2026 was $7,974,743, or $0.46 per share, compared to $4,443,877, or $1.41 per share, in Q3 2025. Total assets as of September 30, 2026, were $29,743,263, with total liabilities of $7,327,897 and total stockholders’ equity of $22,415,366. The company had 10,039,183 shares of common stock issued and outstanding as of September 30, 2026. Weighted-average common shares outstanding for Q3 2026 were 17,462,898. The company will host a conference call and webcast on November 10, 2026, at 8:30 AM Eastern Time to discuss these results.

Cellectar Biosciences Reports Case Study Highlighting Complete Response Lasting More Than Eight Years in Heavily Pretreated DLBCL Patient Treated with Iopofosine I 131

(NASDAQ:CLRB) Cellectar Biosciences, Inc. reported results from a case study of a 53-year-old woman with high-grade, double-hit diffuse large B-cell lymphoma (DLBCL) who had received four prior lines of therapy and stem cell transplantation. The patient received a single dose of iopofosine I 131 (57.5 mCi) on March 20, 2018. By Day 48, the patient achieved a partial response or better, and by Day 85, a complete response was confirmed by both site investigators and sponsor assessment. The target lesion shrank from 825 mm³ at baseline to complete resolution (0 mm³) by Day 85. As of May 2026, more than eight years after the single infusion, the patient has experienced no disease progression and has required no additional anticancer therapy. Duration of response, progression-free survival, and time to next treatment remain ongoing and unreached at more than eight years. The patient experienced expected hematologic toxicities, including anemia, lymphopenia, thrombocytopenia, and neutropenia, all of which resolved. Cellectar plans to submit these findings for journal publication or presentation at a medical meeting. James Caruso, president and chief executive officer of Cellectar, stated that the results further validate the PDC platform's ability to selectively target malignant cells. The company is advancing its confirmatory Phase 3 study in Waldenström macroglobulinemia (WM) and expects to initiate patient dosing in the first quarter of 2027, with plans to submit an accelerated approval application to the U.S. Food and Drug Administration in the first half of 2027. The case study aligns with efficacy and durability observed in Cellectar's Phase 2b CLOVER WaM study in relapsed/refractory Waldenström macroglobulinemia, where iopofosine has generated durable responses in heavily pretreated patients, including those refractory to prior therapies. Jarrod Longcor, chief operating officer of Cellectar Biosciences, commented that the findings reinforce the compelling clinical activity observed in the Phase 2b CLOVER WaM study, including responses in patients refractory to Bruton’s Tyrosine Kinase inhibitors. Iopofosine I 131 is a novel phospholipid drug conjugate (PDC) designed to provide targeted delivery of iodine-131 directly to cancer cells and has been tested in Phase 2b trials for relapsed or refractory Waldenström Macroglobulinemia (WM), multiple myeloma (MM), and central nervous system (CNS) lymphoma. Iopofosine I 131 has also been tested in the CLOVER-2 Phase 1b study in pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications, and the EMA has granted iopofosine I 131 PRIority MEdicines (PRIME) designation. Cellectar is also developing CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors such as triple negative breast (TNBC), lung, and colorectal cancer, currently being evaluated in a Phase 1b study for TNBC to determine the recommended dose for a subsequent Phase 2 trial. CLR 125 has been well tolerated in vivo and has demonstrated strong preclinical data showing reduction or inhibition of solid tumor growth. Additionally, Cellectar is developing CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors in indications with significant unmet need, such as pancreatic cancer, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

Cellectar Biosciences Presents Compelling Efficacy Data from Phase 2b CLOVER WaM Subset Analysis of Iopofosine I 131 in Patients Relapsed/Refractory to BTK Inhibitor Therapy at the International Workshop for Waldenström Macroglobulinemia

(NASDAQ:CLRB) Cellectar Biosciences, Inc. announced efficacy results from a subgroup of 24 patients treated with iopofosine I 131 immediately after Bruton Tyrosine Kinase inhibitor (BTKi) therapy in the Phase 2b CLOVER WaM clinical trial for relapsed or refractory Waldenström macroglobulinemia (WM). The data were presented at the International Workshop for Waldenström Macroglobulinemia (IWWM) held October 14-16, 2026. In this subgroup, 75% were BTKi refractory and more than 54% had received multiple BTKi therapies. Patients had a median of three prior lines of therapy (range 2-7), with 17% being TP53 mutated and 29% being MYD88 wild type. The overall response rate (ORR) was 87.5%, the major response rate (MRR) was 79.2%, and the clinical benefit rate (CBR) was 100%. The median duration of response (DoR) was 16.0 months, and treatment free survival (TFS) was 19.1 months. Treatment emergent adverse events (TEAE) occurred in less than 10% of patients, with the only Grade 3 or higher TEAE being cytopenias. Cellectar is advancing plans to dose the first patients in a confirmatory Phase 3 randomized clinical trial in a post-first line, post-BTKi population, with progression-free survival (PFS) as the primary endpoint. The company is preparing to submit a New Drug Application for accelerated approval with the U.S. Food and Drug Administration (FDA) in the first half of 2027, supported by the CLOVER WaM dataset. The CLOVER WaM dataset includes use of surrogate endpoints (MRR supported by DoR), demonstration of durable responses in a high unmet need population, and completion of at least 12-month follow-up across all patients. Iopofosine I 131 has received Breakthrough Therapy Designation, six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations from the FDA, and PRIME designation from the EMA. The company’s pipeline also includes CLR 121125 (CLR 125), an iodine-125 Auger-emitting program for solid tumors, currently in Phase 1b for triple negative breast cancer (TNBC), and CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors such as pancreatic cancer. CLR 125 has shown strong preclinical data and has been well tolerated in vivo. Cellectar is also developing proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.